Reducing HIV/STD Risk in African American Women With At-Risk Male Partners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 4
- 主要终点
- Change in bacterial STDs from baseline
研究概览
简要总结
The FemAALES Project is a community collaborative two-arm intervention designed to prevent HIV (human immunodeficiency) and STD (sexually transmitted disease) infection and transmission among African American women and men by reducing sexual risk factors and enhancing sexual negotiation skills. The team of investigators is a collaboration of researchers and community service providers who are committed to developing prevention interventions that employ holistic and culturally relevant approaches. This includes recognizing the impact of forces such as racism, sexism, and gender expectations on individual behavior and relationship dynamics in African American communities. Specifically, the investigators hypothesis is that compared to the control condition the FemAALES intervention arm will reduce risky sexual behavior and STI (sexually transmitted infection) incidence and will increase condom self-efficacy and risk behavior communication with sexual partners.
详细描述
Two thirds of female HIV/AIDS cases occur in Black women and an estimated 76% of these are attributed to heterosexual contact. HIV is the third-leading killer of Black women ages 25-44, and STI associated morbidity may contribute to racial disparities in cervical cancer, adverse pregnancy outcomes, and infant mortality.
The investigators propose to test the efficacy of the FemAALES of African American Legacy Empowering Self Intervention in a population of adult Black/African American women who have either no health insurance or a public/subsidized form of health insurance against a Control or "Standard of Care" arm involving family planning and STI counseling.
In addition, the investigators will explore the impact of the FemAALES intervention on the use of new media for social support and networking, obtaining health information, and identifying resources and services. FemAALES incorporates cultural contextual, and partnership issues and promotes access to resources not readily available to this population. FemAALES curriculum is guided by the Theory of Reasoned Action and Planning and Critical Thinking and Cultural Affirmation Model developed by a collaborating community-based organization.
The primary specific aims are to:
- Determine the impact of the FemAALES of African American Legacy Empowering Self (FemAALES II) on HIV risk factors including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female sex
- •self-identifies as Black/African American
- •18 years of age or older
- •English speaking
- •has had unprotected vaginal or anal sex in the last 90 days
- •any male partner in the last 90 days has done one or more of the following: had sex with a man; had sex with a male-to-female transgender; used crack cocaine, heroin, or methamphetamines; been incarcerated for more than 6 months; had sex with other female partners during the relationship; OR - a male partner in the last 90 days has an unknown sexual history
- •publicly funded or public subsidized health insurance
排除标准
- •participated in a small group HIV prevention program in the past 12 months, participated in HARRP program in the past 12 months, has private insurance, refuses chlamydia or gonorrhea test at baseline,
研究组 & 干预措施
FemAALES
Females of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention.
干预措施: Standard of Care (Behavioral)
FemAALES
Females of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention.
干预措施: FemAALES (Behavioral)
Standard of Care
A one-time STD/family planning testing and counseling session provided to all study participants.
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
Change in bacterial STDs from baseline
时间窗: 9 months
Examine the impact of the FemAALES interventions compared to the control condition on the incidence of gonorrhea and chlamydia.
Change in number of sex partners from baseline
时间窗: 3 and 9 months
Determine the impact of the FemAALES intervention compared to the control condition on the number of vaginal and anal sex partners in the prior 90 days .
Change in frequency of unprotected sex from baseline.
时间窗: 3 and 9 months
Determine the impact of the FemAALES interventions compared to the control condition on the number of vaginal or anal sex acts reported without condoms in the prior 90 days.
次要结局
- Change in Safer Sex Negotiation Skills and Behaviors(3 and 9 months)